Capoten ANDA approvals would render Waxman/Hatch 3-year exclusivity "largely meaningless" -- Bristol suit.

Executive Summary

CAPOTEN ANDA APPROVALS WOULD MAKE WAXMAN/HATCH EXCLUSIVITY "MEANINGLESS," Bristol-Myers Squibb maintains in a recent court filing in a civil case challenging FDA's implementation of the Waxman/Hatch three-year exclusivity provisions for new indications. The suit points out that state and private formularies often encourage or require the substitution of an "AB"-rated generic when one is available without regard to indication. Those substitutions render "any patent protection or non-patent exclusivity rights covering the supplemental indication largely meaningless," Bristol declares.